Evaluation of a Comprehensive School Health Programme in Zambia

NCT ID: NCT06560853

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2026-11-30

Brief Summary

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In Zambia, the health and well-being of children aged 5 to 14 has often been overlooked, leading to various health challenges affecting their development and education. The Healthy Learners (HL) program, in collaboration with the Zambian Government, aims to address this gap by implementing a comprehensive school health program. Trained teachers, known as school health workers (SHWs), play a key role by delivering health education, coordinating preventative care with local clinics, and overseeing a 'school health room' for sick students.

This study is a large cluster-randomized control trial in 225 schools. The goal of this trial is to compare the effects of the comprehensive school health programme (SHP) developed by HL against two alternatives: the current level of school health provision and the current school health activities enhanced with deworming and vitamin A coordination by HL, with their technical and financial support ensuring the reliable delivery of all health activities currently planned by the government.

1. What is the impact of the program on health-seeking, health, and education outcomes?
2. What are the indirect effects of the program on teachers and clinics?
3. What is the added value of such a comprehensive SHP, compared to (i) optimized (ii) or imperfect (status-quo) delivery of a limited range of school health activities (e.g., deworming and vitamin A supplements)?
4. How costly is the comprehensive SHP, and what factors affect its implementation?
5. What are the potential benefits of the program for long-term human capital accumulation (learning, well-being etc)?

Detailed Description

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Conditions

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Helminth Infection Malaria Schistosomiasis Anemia UTI Diarrhea Skin Rash Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clusters (schools) are randomised to one of 3 treatment arms. Non-compliance with treatment or control is possible if participants move between schools. We expect low rates of transfers and will track any transfers which do occur.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Blinding of intervention units, i.e. schools, to their own treatment (or that of others) is not feasible. After the initial scoping and baseline data collection (during which treatment was masked to all participants and assessors), due to the nature of the intervention, there will be no blinding: both the beneficiaries and assessors monitoring the outcomes will be able to infer whether the school is receiving the HL programme or not.

Study Groups

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School health programme (SHP)

SHP developed by Healthy Learners (HL) in collaboration with the Ministry of Education (MOE), which follows the WHO guidelines on school health activities. HL supports the upgrading of basic sanitation facilities and construction of a dedicated 'health room' in the school; trains selected teachers to become school health workers (SHWs) who deliver health and sanitation education, coordinate deworming and vitamin A supplementation in the school, and assess sick learners in the school health room using a clinical decision support system (CDSS), either treating in school or referring to the local health centre. At the health centre, children referred by SHWs are given priority by health care workers who see them within 30 minutes of arriving at the facility. Schools also create student networks (a "buddy" system) whereby learners monitor each other's absence and coordinate with SHWs, who can then follow up with the household.

Group Type EXPERIMENTAL

Comprehensive School Health Programme

Intervention Type OTHER

Combination intervention which consists of:

* Upgrading sanitation facilities and constructing a 'health room' in the school
* Health teacher training: 5-10 teachers per school are recruited and trained for two weeks to become School Health Workers (SHWs) by Healthy Learners
* The SHWs: (1) deliver education on health and good sanitation and hygiene (2) coordinate with local clinics to deliver preventive care (e.g. school deworming and vitamin A supplementation); (3) assess sick students in the health room with a tablet-based clinical decision support system (CDSS); (4) treat sick students in the health room for some conditions (malaria, diarrhoea, schistosomiasis, pneumonia, conjunctivitis) or (5) refer to the health facility for treatment; (6) monitor absence of learners
* Referral: learners referred by SHWs are given a referral form by the SHW, which contains information about symptoms and suggested diagnosis by the CDSS. The learners are prioritised in the local clinic.

Deworming and vitamin A supplementation delivery

Intervention Type OTHER

Schools implement the government policy of distributing deworming drugs and vitamin A supplementation to learners twice a year. Additional support from Healthy Learners ensures reliable delivery.

Deworming and vitamin A supplementation

Healthy Learners will enusre reliable delivery of the national deworming programme twice a year, during the same period as in the SHP arm, for comparability of the effect of prevention alone to the full SHP.

Group Type ACTIVE_COMPARATOR

Deworming and vitamin A supplementation delivery

Intervention Type OTHER

Schools implement the government policy of distributing deworming drugs and vitamin A supplementation to learners twice a year. Additional support from Healthy Learners ensures reliable delivery.

Status quo

Schools to operate as usual with no intervention other than the usual activities planned and organized by the government, as set out the 2006 School Health and Nutrition Policy, until the end of the trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Comprehensive School Health Programme

Combination intervention which consists of:

* Upgrading sanitation facilities and constructing a 'health room' in the school
* Health teacher training: 5-10 teachers per school are recruited and trained for two weeks to become School Health Workers (SHWs) by Healthy Learners
* The SHWs: (1) deliver education on health and good sanitation and hygiene (2) coordinate with local clinics to deliver preventive care (e.g. school deworming and vitamin A supplementation); (3) assess sick students in the health room with a tablet-based clinical decision support system (CDSS); (4) treat sick students in the health room for some conditions (malaria, diarrhoea, schistosomiasis, pneumonia, conjunctivitis) or (5) refer to the health facility for treatment; (6) monitor absence of learners
* Referral: learners referred by SHWs are given a referral form by the SHW, which contains information about symptoms and suggested diagnosis by the CDSS. The learners are prioritised in the local clinic.

Intervention Type OTHER

Deworming and vitamin A supplementation delivery

Schools implement the government policy of distributing deworming drugs and vitamin A supplementation to learners twice a year. Additional support from Healthy Learners ensures reliable delivery.

Intervention Type OTHER

Other Intervention Names

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SHP Deworming

Eligibility Criteria

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Inclusion Criteria

* School administrator: has at least one year experience in school and is the primary or deputy school manager (e.g., headteacher, deputy headteacher, senior teacher acting as financial officer)
* Learners: registered and in attendance in school during baseline, in grade 1, grade 3, or grade 5
* Parents, primary caregivers or guardians of selected learners. Guardians are eligible if they stay with the child and make schooling and health decisions for the child in the absence of parents/primary caregivers.
* Teachers: any teacher employed by study eligible schools (not volunteers)
* Health facilities: designated facilities in the catchment area of study schools
* Health facility staff: any staff doing OPD consultation present during facility data collection days
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

Healthy Learners

UNKNOWN

Sponsor Role collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

London School of Economics and Political Science

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mylene Lagarde, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Economics and Political Science

David Ross, PhD

Role: STUDY_CHAIR

University of Stellenbosch

Locations

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Chingola District Education Board

Chingola, Copperbelt, Zambia

Site Status

Luanshya District Education Board

Luanshya, Copperbelt, Zambia

Site Status

Masaiti District Education Board

Masaiti, Copperbelt, Zambia

Site Status

Kawambwa District Education Board

Kawambwa, Luapula Province, Zambia

Site Status

Mwense District Education Board

Mwense, Luapula Province, Zambia

Site Status

Samfya District Education Board

Samfya, Luapula Province, Zambia

Site Status

Countries

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Zambia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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264865

Identifier Type: -

Identifier Source: org_study_id

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